Everything a PI Needs to Know about LCCC as an IND Sponsor
Course DescriptionKaitlin Morrison, PhD takes you through the sponsor responsibilities outlined by Good Clinical Practices (GCP) and FDA regulations and what LCCC infrastructure and processes are used to meet those obligations.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
Everything that a PI Needs to Know about Holding an IND
Course DescriptionKaitlin Morrison, PhD takes you through all of the major responsibilities of holding an LCCC sponsored IND. She takes you through errors made in the past, so you can make sure that you don’t make them on your study.
Category
- Investigator Initiated Trials
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
Gene Therapy- FDA and Local Considerations
Course DescriptionIn this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
Hot and Cold Topics for Investigators
Course DescriptionKaitlin Morrison, PhD takes you through the top topics investigators are asking about and the other questions that they should be asking too.These topics include:
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
IIT FDA Annual Reports
Course DescriptionNasrin Babadi, PhD takes you through how to write an IND annual report and the LCCC processes surrounding IND annual reports.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
IIT- Protocol Amendments
Course DescriptionNasrin Babadi, PhD takes you through LCCC’s processes for amending protocols and submitting them to FDA talking about key tips on how to best edit your protocol and applicable FDA regulations for submitting your protocol.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
IND Safety Reporting- LCCC IITs
Course DescriptionIn this talk, Kaitlin Morrison, PhD covers how to fill out a MedWatch report form and how/when/why to notify FDA of an SAE.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
LCCC’s Single Subject Exception Policy
Course DescriptionIn this talk by Kaitlin Morrison, PhD and Carrie Lee, MD, MPH, Kaitlin takes your through LCCC’s policy on single subject exceptions, why we do not allow eligibility single subject exceptions on IITs and what the process is to ensure
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
Project Management of CPO Trial Activation 101
Course DescriptionThis lecture takes you through business principles as defined by “Project Management: A Systems Approach to Planning, Scheduling and Controlling” by Harold Kernzer. Kaitlin Morrison, PhD will cover what is traditional vs.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation
Protocol Amendments vs. Administrative Letters
Course DescriptionIn this talk, Kaitlin Morrison, PhD discussing what an administrative letter is and when an administrative letter can be used to clarify a clinical protocol versus when a full amendment is required.
Category
Format
- Self-Paced, Online Courses
Credits
- 1.00 Participation